- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07575126
Comparison of Qigong and Otago in Patient With Diabetic Neuropathy
Comparison of Qigong and Otago on Agility, Balance, Gait, and Quality of Life in Patients With Diabetic Neuropathy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muneeb Khan, PhD
- Número de teléfono: +92336799611
- Correo electrónico: muneeb.khan@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Guiranwala, Punjab Province, Pakistán, 54500
- DHQ Gujranwala
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Contacto:
- Javeria Ghazal, MS
- Número de teléfono: +923335154664
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Investigador principal:
- Junaid Raza, MS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Physician-diagnosed type 2 diabetes without gender bias, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater)
- Type 2 diabetic peripheral neuropathy patients
- The ability to walk independently for 10 m
- Having score between 46 to 52 (out of a total of 56 points) on the BBS
Exclusion Criteria:
- Fracture of the lower limb within the 6 months before the study (15)
- Diabetic ulcer, infection or partial amputation in feet (15)
- Disease or functional impairment of auditory, vestibular system (16)
- Any other medical conditions that would confound assessment of neuropathy such as malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis (17)
- Dementia or inability to give consistent information (18)
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Qigong Balance
|
Quigong Balance Exercises 3 times per week for 60 minutes per session Open the Flow: Focus on fluid arm movements to enhance relaxation and improve circulation. Shaking Exercise: A full-body shake to release tension and promote energy flow. Lifting the Ball: Alternating arm movements simulating lifting a ball to improve upper body strength and coordination. Playing with Water: Slow, flowing movements that enhance balance and mindfulness. Weight Shifting and Balance Exercises: Stand with feet hip-width apart, shifting weight slowly from one leg to the other, holding each position for 10-15 seconds to engage stabilizing muscles in the legs and improve proprioception. Leg Lifts and Extensions: Perform controlled leg lifts (front, side, and back) to strengthen the quadriceps, hamstrings, and hip abductors. |
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Comparador activo: Otago Balance
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Otago (Strengthening) Balance: Sit-to-stand exercises: to improve leg strength. Heel raises: to enhance calf strength. Toe stands: for improving foot stability. Balance Training: Single-leg stands: to enhance balance. Tandem walking: along a straight line. Side leg raises: to strengthen hip muscles 3 times per week for 60 minutes per session |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Agility T-Test
Periodo de tiempo: 12th week
|
The Agility T-Test is a performance-based assessment that measures an individual's agility and ability to change direction quickly.
It involves a sequence where the participant runs to a designated point, makes sharp turns around markers in a T-shaped layout, and returns to the starting position.
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12th week
|
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Berg Balance Scale
Periodo de tiempo: 12th week
|
is the gold standard test for static and dynamic balance abilities.
The BBS is used to measure ability to maintain balance while doing functional task search as reach, standing position and transferences.
It is a valid instrument used for the evaluation of effectiveness of interventions with quantitative description of function in clinical practice as well as research.
It consists of 14 items including simple balance tasks from everyday life.
|
12th week
|
|
Functional Reach Test
Periodo de tiempo: 12th week
|
FRT is a single item test for dynamic balance and acts as a quick screen for balance problems in older adults.
The distance between the lengths of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support is measured.
A score of 6 inches or less indicates a significant increased risk for falls.
A score between 6-10 inches indicates a moderate risk for falls.
the Functional Reach Test (FRT) demonstrates an ICC of approximately 0.85 to 0.94
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12th week
|
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Gait Speed Test
Periodo de tiempo: 12th week
|
The Gait Speed Test measures the time it takes for an individual to walk a specific distance, usually 10 meters, at their usual pace.
It has demonstrated strong validity and reliability, with an Intra class Correlation Coefficient (ICC) often exceeding 0.90
|
12th week
|
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10-Meter Walk Test
Periodo de tiempo: 12th week
|
The 10-Meter Walk Test involves timing a participant as they walk a distance of 10 meters at their comfortable pace.
It assesses gait speed, which is an important indicator of mobility and overall functional ability.
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12th week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Javeria Ghazal, MS, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR &AHS/24/0297
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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